Salutaris Medical Devices (SMD) is a clinical-stage medical device company specializing in the treatment of ophthalmic diseases with a precision beta radiotherapy delivery platform.
Our globally-patented, 510k-cleared device has the potential to treat various challenging retina diseases in an accessible, safe, and effective manner.
We recently obtained FDA-clearance to conduct a pivotal study and will pursue the on-label approval for the indication of PCV (Polypoidal Choroidal Vasculopathy), the most difficult to treat form of wet-AMD (Advanced Age-Related Macular Degeneration).
Anti-VEGF Resistant Disease
20+ million seniors suffer vision loss from wet-AMD (advanced age-related macular degeneration).
The current treatment for wet-AMD is frequent (sometimes monthly) injections of anti-VEGF directly into the eye.
This treatment is a $15+ billion industry but these lifetime injections produce disappointing results in up to 60% of wet-AMD patients.
Many of these non-responsive patients often suffer from a subtype, PCV (polypoidal choroidal vasculopathy), that remains under-diagnosed outside of Asia due to its disproportionate impact on darkly pigmented individuals. PCV has proven to be a difficult puzzle to solve.
We applied a well-understood therapeutic approach to the most challenging form of wet-AMD.
Our episcleral brachytherapy is an outpatient procedure.
The individualized dwell time ensures the exact dose of beta radiotherapy.
The retina surgeon targets the offending lesion precisely.
Capillary versus Arteriolor CNV
Choroidal Neovascularization (CNV), the underlying cause of wet-AMD, appears to have multiple pathogenic mechanisms beyond VEGF. Classic capillary CNV is VEGF induced and responds best to anti-VEGF therapy. In contrast, arteriolor CNV seen in minimally classic and occult lesions appear less responsive to anti-VEGF monotherapy, suggesting alternative pathogenesis.
Fortunately, radiation oncologists know from 50+ years of prior experience treating arteriovenus malformations (AVM) in the brain that ionizing radiation can safely treat all forms of CNV, including those exhibiting anti-VEGF resistance.
CNV is a complicated disease that requires a multi-targeted and comprehensive treatment. The radiotherapy puzzle is precise and safe beta particle dosimetry in the hands of a vitreoretina surgeon in an outpatient setting. The SMD BetaCurve™ solves this puzzle perfectly.
- Effective against classic wet-AMD caused by VEGF that affects mostly Caucasians asd asdasdfasdfasdfasdf asdfasdfasdfasdfasdf
- Improvement in visual acuity is palliative since underlying disease progression often persists aasd aasd asd asd asd asd asd asd asdasd. we e asd a
- Requires “lifer” injections (monthly for recalcitrant subtypes) asd asd asd asd asd asd asd asd asd asd asd aasd asd asd asd asd asd asd asdasd. we e asd a
- Anti-VEGF treatment is often impermanent and patients quit injections as early results fade asdfasdfasdfasdfasdfasdf asd asd asd asd asd asd asdasd. we e
- Creates a treatment burden amongst due to needle anxiety, Covid19 exposure fears, and simple scheduling logistics asdfasdf asdfasdf asdfasdf asdfasdf
- Current research correlates possible link between anti-VEGF injection frequency and vascular dementia asdfasdf asdfasdf asdfasdfasdfasdf
- Frequent visits for anti-VEGF injection amongst elderly is not practical in many countries around the world
- We expect our pivotal trial to show efficacy against wet-AMD with non-VEGF pathogenisis that most often affects darkly pigmented eyes aasd asd asd. asd asd. asd asd asd. asd
- Improvement in visual acuity anticipated to accompany reduction or elimination of underlying disease activity asd asd asd asd asd asd asd asd sd fasdasdf asdfasdf
- One-time treatment may reduce or eliminate injections altogether regardless of the subtype asdfasd f asd asd asd asd asd asd asdasd. we e asdfasdf asdfasdf asd asd
- Radiotherapy may prove to be durable and last a lifetime asdasasasdfasdfasdfasdfasdfasdfasaasd asd asd asd asd asd asdasd. we e sd asd asdasdsa asdas
- Regular treatment visits are not required for the painless, minimally-invasive, one time procedure asd asd asd asd asd asd asdasd. we e asdfasdfasdfasdfasdfasasd
- Precision radiotherapy will minimize side effects from frequent injections in recalcitrant subtypessdthetowers asd asd asand public health agencif a
- One-time SMD precision radiotherapy can be made available everywhere asdfa asdfasfg asdfasdf asdfasdf asd
George Mimura is the Chairman and CEO of Salutaris Medical Devices (SMD). He worked on Wall Street for 25-years where he held senior management positions in equity, fixed income, and currency businesses in New York, Tokyo, London, and Sydney. Throughout his career he has invested in and advised a range of entrepreneurial startups.
Mary Drew serves as Director of Clinical Operations and has been with SMD since 2010. She is responsible for managing the Pilot, Feasibility, and the current FDA-cleared Pivotal Study. She has comprehensive experience in clinical trials in various therapeutic areas including; cardiology, endocrinology, pain, dermatology and women’s health.
Ryan Lohrenz is the COO of SMD. He designed and developed the current SMD-DA Applicator and Source. He has 10+ years of management, engineering, and medical product design, and development experience. Previously, Ryan acquired significant expertise with the 510(k) and CE Marking process of new devices at Bioptics (presently Faxitron X-Ray).
Hailey Davenport held the position of Clinical Data Coordinator at SMD. She has experience as a research specialist and clinical research coordinator for the University of Arizona. She has coauthored multiple scientific publications in the field of molecular endocrinology. She received her B.S in Biomedical Engineering from the University of Arizona.Bioptics (presently Faxitron X-
Dr. Hamilton is a board-certified medical physicist specializing in radiation therapy. He is currently a tenured professor at the University of Arizona where he founded the medical physics graduate and residency program. He graduated summa cum laude with a BS in Physics from the University of Illinois and earned a PhD at Stanford University in theoretical astrophysics.
Dr. Stea is a board-certified radiation oncologist specializing in the treatment of brain tumors and pediatric cancers, including total body irradiation (TBI). He developed the stereotactic radiosurgery program at the University of Arizona, utilizing novel radiation enhancers and radio-sensitizing drugs for brain tumors. He has a PHD from UCLA and his MD from George Washington University.
Dr. Kokame is Chief of the Division of Ophthalmology for the Department of Surgery in the John A. Burns School of Medicine at the University of Hawaii. He has directed The Retina Center at Pali Momi into a nationally and internationally recognized center for retinal research and education. He has authored over 70 scientific papers in peer-reviewed journals, and is a consultant and reviewer for all the major journals in ophthalmology. He completed his residency at the Jules Stein Eye Institute at the UCLA School of Medicine and completed his Vitreoretinal Surgery Fellowship at Bascom Palmer Eye Institute at the University of Miami School of Medicine in Miami, Florida.
Jay Chhablani is a vitreo-retina specialist and Associate Professor at the University of Pittsburgh Eye Center. He completed a clinical fellowship at Sankara Nethralaya, Chennai, India and was an International Council of Ophthalmology fellow at Jules Gonin Eye Hospital, Switzerland. He was a Clinical Instructor at the Jacobs Retina Center at Shiley Eye Center, University of California, San Diego, USA (2010-2012) before joining the faculty at L V Prasad Eye Institute, Hyderabad, India (2012-19). He published three books and more than 400 articles in peer-reviewed journals. He is on the reviewing boards of all high-impact journals, including Science Translational Medicine and Lancet.
Dr. Jager, M.D., M.B.A., F.A.C.S., is a board-certified ophthalmologist and vitreoretinal surgeon. He is the President and Managing Partner of University Retina. He also serves as Clinical Professor of Ophthalmology at the University of Illinois at Chicago / Illinois Eye and Ear Infirmary.
Dr. Jager has authored over 60 scientific papers, book chapters, and national meeting presentations with published abstracts. He has also co-authored three books in ophthalmology, Age-Related Macular Degeneration: A Comprehensive Text and the third and fourth editions of the Massachusetts Eye & Ear Review Manual for Ophthalmology.
- Vitreoretinal Fellowship: Harvard Medical School / Joslin Diabetes Center (ADA)
- Ophthalmology Residency: University of Chicago
- Medical School: Northwestern University Medical School
- Business School: Stanford University Graduate School of Business
- Undergraduate: Northwestern University, Biomedical Engineering
- High School: Marist High School, Chicago, IL (Valedictorian) asdasd asd asd asd as asd asd asd asd asd asd asdasd asd asdasd asd asd asd asd asd asd asd
Dr. Bhisitkul, Professor of Ophthalmology at the University of California San Francisco School of Medicine, has over 20 years of experience as a retina surgeon and clinician scientist. Dr. Bhisitkul graduated from Stanford University then combined medical school at Stanford with his PhD in Neurosciences at Yale University, followed by residency and fellowship training at Harvard Medical School/Massachusetts Eye and Ear Infirmary. His translational research interest is in pre-clinical development of novel technologies for ophthalmic disease. In clinical research, he is an investigator in major clinical trials of novel ophthalmic therapeutics, as well as studies of long-term outcomes of drug treatments for chronic eye disease. He is Fellowship Director for the UCSF Retina Surgery program. He is an Associate Examiner for the American Boardof Ophthalmology, a recipient of the American Academy of Ophthalmology Achievement Award, and an editorial board member of American Journal of Ophthalmology Case Reports. He acts as consultant and medical advisor for ophthalmologic pharmaceutical companies in designing early stage trials and conducting clinical development of new ocular therapies.
Robert Selby, MD
Robert Selby, MD, is a Director of SMD. Dr. Selby is board-certified in internal medicine and dermatology. Previously, he served as Assistant Professor at the University of Arizona School of Medicine, Department of Internal Medicine and Dermatology. Dr. Selby is also an experienced biotechnology investor and a commercial real estate developer. He received his MD from the University of Arizona College of Medicine. asd asd asd asd asd asd asd asd asd asd asd asd asd
William H. Lomicka is a Director of SMD. He is the Founder and Chairman of Coulter Ridge Capital. He enjoyed a career at Humana, where he ended up as Senior VP-Finance & Treasurer. He also served as the Secretary of Commerce of the Commonwealth of Kentucky and founded several entrepreneurial companies. He earned a BA from the College of Wooster and an MBA from the Wharton School at the University of Pennsylvania.
Venerable Tenzin Priyadashi is a Director of SMD. Venerable Tenzin Priyadarshi is an educator, innovative thinker and polymath monk. His unusual background encompasses entering a Buddhist monastery at the age of ten and receiving graduate education at Harvard University with degrees ranging from Philosophy to Physics to International Relations. He is a Tribeca Disruptive Fellow and a 2018 Fellow at the Center for Advanced Study in Behavioral Sciences at Stanford University. Venerable Tenzin serves on the boards of number of academic, humanitarian, and religious organizations. He is the recipient of several recognitions and awards, and received Harvard’s Distinguished Alumni Honors for his visionary contributions to humanity.